GDUFA Research Outcomes

Ophthalmic-Otic Products

• All(147)
• Posters(63)
• Presentations(30)
• Papers(54)

• Physiologically-based Pharmacokinetic Modeling to Support Generic Ophthalmic Product Development and Regulatory Decision Making

  Tan, Mingliang

• Developing Discriminatory IVRT Methods for Injectable Suspensions: Start with Why

  Smith, William C

• Intravitreal Sustained Release Ganciclovir: An Orphan Generic

  Smith, Thomas

• In vitro and in vivo characterization of ophthalmic suspensions

  Sailor, M

• Regulatory Uses of IVRT Studies on Complex Generic Ophthalmic, Injectable, Implantable, and Inserted Products

  Qin, Bin

• Novel In Vitro, Ex Vivo and In Vivo Assessment of Ophthalmic Semi-Solid Drug Products

  Lu, Xiuling

• Considerations for Post-Approval Changes to Complex Generic Drug Products

  Kozak, Darby

• A Scientific and Regulatory Overview of IVRT: Current Considerations and Challenges

  Kozak, Darby

• Formulation Considerations for In Vitro Characterization Based Approaches of Locally Acting Complex Generic Drug Products

  Kozak, Darby

• Approaches Using Proactive Research in Support of Product-Specific Guidance (PSG) Development

  Xu, Xiaoming